Annual Fee 2022
Following the UK’s departure from the EU, the ‘safety features’ Delegated Regulation (EU) 2016/161 no longer applies in Great Britain (England, Scotland and Wales) but still applies in Northern Ireland.
The UK is committed to meeting the requirements of EU FMD safety features Delegated Regulation in Northern Ireland, and the MHRA expect all stakeholders in the supply chain to comply with these requirements.
MAHs are obliged to contract with and pay fees to SecurMed if their Marketing Authorisation is valid in Northern Ireland.
The SecurMed Board met in October 2021 and set the fees for the UKNI MVS from January 2022 as follows:
- A one-off set-up fee of GBP £1,000 is payable upon registration (This does not apply to MAHs already registered with SecurMed).
- An Annual MAH Operational Fee of £2,500.
The Micro Fee Waiver scheme is unchanged. Please see the explanation on how to apply here.